A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients.

Endpoint Classification: Safety/Efficacy StudyIntervention Model: Single Group AssignmentMasking: Open Label

Official Title:

Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg

Further study details as provided by Otivio AS:

Primary Outcome Measures:

% of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF) [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]

This is calculated as the difference between the blood flow during the period using FlowOx™ (middle value over a period of 5 minutes) and baseline blood flow (middle value over a period of 5 prior to using FlowOx™)

Secondary Outcome Measures:

Patient comfort measured by asking the patient a fixed set of questions [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]

Other Outcome Measures:

Fitting time [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]

Currently treated for cancer and With a life expectancy of less than 2 years

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01893840